A First Time in Man Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1979 in Healthy Males

Healthy Subjects Clinical Trial

Official title:

A Phase I, Single-center, Single-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of Oral AZD1979 After Single-ascending Doses in Healthy Male Volunteers

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02072993
• Other study ID #: D3930C00001
• Status: Terminated
• Phase: Phase 1
• First received: February 25, 2014
• Last updated: July 28, 2014
• Start date: March 2014
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a first time in human study to assess the safety and tolerability of AZD1979 following oral administration of single ascending doses in healthy male volunteers. Pharmacokinetics (what the body does to the drug) parameters will also be assessed as secondary objectives.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 116
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Provision of signed and dated, written informed consent prior to any study specific procedures

• Healthy male volunteer aged 18 to 50 years

• Have a BMI between 18 and 30 kg/m2, inclusive, and weigh at least 50 kg and no more than 100 kg, inclusive

Exclusion Criteria:

• History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study

• History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs

• Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IP

• Any clinically important abnormalities in clinical chemistry, endocrine hormones, hematology, or urinalysis results as judged by the Investigator

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• AZD1979
Single dose, oral solution administration
• Placebo to match
Single dose, oral solution administration

Locations

Country	Name	City	State
United States	Research Site	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety variables in terms of: Adverse events, clinical laboratory variables, vital signs, electrocardiograms and telemetry, physical examinations, and assessments of anxiety and mood		Up to 62 days	Yes
Secondary	Pharmacokinetics of AZD1979 assessed by means of plasma concentration analyses		up to 48 hours post dose	No